In response to the opioid epidemic that has swept the country, the Centers for Disease Control and Prevention released long-anticipated guidelines on prescribing opioid painkillers such as OxyContin and Percocet.
They were published Tuesday in JAMA, the Journal of the American Medical Association.

The advice is aimed at primary care physicians, who prescribe nearly half of the opioid painkillers consumed in the U.S. The guidelines aren’t intended for doctors treating cancer patients or for end-of-life care.

The guidelines sparked controversy when a draft was released in the fall. Some pain specialists and patient advocates cited a lack of evidence supporting many of the recommendations. Critics voiced concern that the guidelines could result in patients being denied pain relief they legitimately need.

NPR’s Robert Siegel spoke with Dr. Debra Houry, director of the Centers for Disease Control and Prevention’s National Center for Injury Prevention and Control, who’s been involved in the development of the guidelines from the beginning.

Here are interview highlights, edited for length and clarity.

On how Houry hopes the guidelines will change the way doctors treat pain
I hope this will allow primary care providers to have a conversation with patients about the risks and benefits of opioids and to consider non-opioids as the first-line treatment for pain.

The doctor can tell you that up to 1 in 4 patients with chronic pain can experience opioid dependence. A family history of addiction, mental health issues and other chronic issues can put you at higher risk.

On the potential pushback from people in chronic pain
What I would say is, let’s try some other options first. Let’s try a high dose of a nonsteroidal [anti-inflammatory drug], let’s try an SSRI-type medication, let’s try some of these other medications first and maximize them. We absolutely want to treat your pain, but we want to do it safely. And opioids may be warranted. … If opioids are warranted though, we’re not saying to use them in isolation. They should be used in combination with things like exercise therapy or nonsteroidal medication.

Critics, including the American Academy of Family Physicians, faulted the CDC’s initial recommendation that opioids should not be first-line therapy for chronic pain, saying that’s too strong a stance given the weakness of the evidence.
Well, I think there is weakness [in evidence] on the benefits of opioids but there’s been significant progress on the risk of opioids. We see that there is an increased risk of car crashes, death from overdose. And that’s why we have decided that because of that, and the uncertain benefits of opioids, that continuing to prescribe them for chronic pain is not warranted. On the other end, non-opioids, there is evidence for their benefits.

There is room for more science as we continue to revise and update the guidelines, but given the number of Americans dying each day from opioid overdoses — 40 a day — we have enough evidence today about the risks. That being said, I can tell you as a practicing physician that many guidelines I use are often based on low-quality events, and that doesn’t mean bad evidence. That just means there are not a lot of randomized controlled trials.

On criticism of the initial recommendation to limit prescriptions for acute pain to three days
So we heard that feedback, and for that specific recommendation there is now a range of up to seven days. We want to make sure patients have appropriate access, but we also want to limit the number of patients who become addicted, Having too many days of medication can put you at risk for addiction, so we do think it is important to give the shortest course possible.

Response to the concern over the low starting dose recommended
We’ve actually put a range in there. At 50 morphine milligram equivalents [a standardized measure of potency], we say that you should assess the risks and benefits. And at 90 you should really think hard … consider referring them to a pain specialist. This is for initiation of opioids. We do not think that an opioid-naive patient — someone who hasn’t been on opioids before — should be started on a high dose of opioids. We have seen that the higher the doses of opioids, the more likely you are to overdose. So we believe in starting low and going slow.

What should doctors tell people who suffer chronic pain and are on opioid therapy now?
It would include having that conversation about the risks and benefits. With the newer evidence we know about the risks, I believe every patient should be aware of the risks and benefits of their treatment. And I do think physicians should routinely monitor their patients and reassess them. If a patient is doing fine on a low dose, we’re not saying to change that care. But if a patient is not improving in function or is having adverse events, I think they should reconsider what medication they’re on.

I WILL BE in chronic physical pain until I die. I’m 53, and this has been true for more than half of my life. I accept it.

Pain medication is inadequate. But with it I am more consistently functional and can minimize being housebound, bedridden, or hospitalized. I can be a responsible homeowner, spouse, parent; I can work as a teacher, a writer, an editor.

I recognize that drug abuse and addiction are serious problems. But ever-tighter regulations, at both the local and national levels, are of dubious value in reducing them — while causing grave harm to those of us in chronic pain, to the overwhelming majority who take medication for appropriate reasons, with effective oversight.

We don’t talk about this much — “They’re-making-it-harder-for-me-to-get-my-drugs’’ isn’t exactly a winning public flag to fly.

I’ve never been arrested, found to be out-of-compliance, had a substance-related accident or hospitalization, but increasingly I am a suspect, treated less as a patient and more as a criminal.

I’ve been subject to drug testing — random-but-regular, bitterness rising — for longer than I can remember. I recognize valid public health concerns associated with taking pain medication: doctor shopping; mixing prescribed drugs, or street drugs, from a variety of sources; people who scam physicians into providing legal prescriptions, then sell the meds on the street. Initially, I didn’t think I would care.

But I do care. The feelings of humiliation and degradation don’t fade; they simmer.

My latest pain contract, presented as a requirement for obtaining care, included a demand that I appear, whenever ordered, before any practitioner in the health maintenance organization to which I belong, within an hour’s time, with my medication bottle in hand.

For a pill count.

How, exactly, is that supposed to work?

I have a job, a family, a life. I can’t carry around a bottle of prescription narcotics; the contract deems loss, theft, or damage as suspicious activity, and the pills would not be replaced. So I would have to interrupt teaching, go home, retrieve the pills, and report to a practitioner.

Within an hour.

I would rarely be able to do this, and when I could, doing so within an hour would usually be impossible. But in failing to comply, I would risk the revocation of my “pain medication license.”

Again, abuse of prescription pain medication is a serious problem; people are dying. But a vastly larger group of us are living — in unremitting pain, in the face of which we do the best we can to remain productive and independent, to benefit, rather than burden, our families and society at large. Most of us have accepted ever-more-onerous restrictions, no matter how humiliating — urination on command, guilty-until-proven-innocent — regardless of how they clash with American values and medical ethics.

Do we have a choice?

Well, sadly . . . yes. Street narcotics. They are broadly available, and they’re less expensive. There’s no oversight, and no humiliating urinalysis.

Canadian endo sister forced to wait for laparoscopy – told she will “not suffer death or irreversible tissue damage”, so she should stop “doctor shopping, since this was a waste of both health-care resources and her time.” She was of course in agonising pain. Turns out once she came to the States to get surgery at Northside Hospital Cancer Institute, the surgeon had to remove her uterus, fallopian tubes, ovaries and nearly 8 inches of her bowel because of extensive endometriosis damage.

OHIP turns blind eye to suffering
COVERAGE: Area woman was chastised for seeking faster care before agency threw up roadblocks to paying for her care
By JONATHAN SHER, THE LONDON FREE PRESS
Last Updated: January 20, 2012 9:55pm

Chastened by doctors for seeking speedier treatment for a painful disease threatening to rob her of fertility, Allison Jones writhed with pain so severe it was like a man continually passing large kidney stones.

Jones needed to see one of a handful of gynecological specialists who could remove the lining of a uterus where it grows outside that organ, a painful condition called endometriosis.

But after waiting seven months to see a specialist Jones, a resident of Southwestern Ontario, was told she’d have to wait at least seven more for surgery that might make her pain-free for the first time in years.

Only one specialist held an open door to her care, a Canadian schooled almost entirely in Ontario. But Dr. Ken Sinervo had committed a Cardinal sin as far as OHIP was concerned — he offered life-changing surgery outside the country in Atlanta, Georgia.

Twice, Jones’ family doctor wrote to OHIP, asking the agency to pay for Siverno’s surgery, but each request was met by quick refusals and a suggestion she check a list of specialists, none of whom had time to see her any quicker.

One specialist, Dr. Sabrina Lee, chastised Jones for seeking faster access, writing in a letter she should stop “doctor shopping, since this was a waste of both health-care resources and her time.”

Jones sought emergency care repeatedly, but the heavy-duty drugs prescribed did little to curb her pain.

So in April of 2010, she decided to go to Atlanta.

Three days later, she was on an operating table at the Northside Hospital Cancer Institute.

“That’s one of the big differences between the health-care system in Canada and the system here,” Sinervo told The Free Press this week from Atlanta.

The disease had progressed so quickly, Sinervo had to remove her uterus, fallopian tubes, ovaries and nearly 8 inches of her bowel.

The ordeal was traumatizing. Jones — not her real name — asked The Free Press last week to keep her identity secret.

But those who helped her spoke out.

It isn’t just the speed of access that’s different, Sinervo says. The surgeries he performs in Atlanta are more advanced than what’s available in Ontario, in part because he performs surgery four or five days a week — while Ontario docs might get a day and a half because of the rationing of operating-room time.

“That’s one of the reasons I didn’t go back to Canada after my fellowship in Atlanta,” he said.

Sinervo uses a carbon-dioxide laser to remove all of the abnormal tissue to lessen the chance of complication and reoccurrences, something he says most specialists do not do.

The surgery was done, but the struggle for Jones had just begun: She faced a $70,000 medical bill including close to a week in hospital.

The Atlanta hospital, Northside Hospital Cancer Institute, later forgave most of the bill, wiping $57,000 off the books as it sometimes does for patients who just can’t afford to pay.

But OHIP fought against covering the remaining $13,000, even though that amount is almost certainly no more than what Jones’ treatment would have cost in Ontario, Sinervo said.

That hard-nosed approach is nothing new for OHIP, says the lawyer who represented Jones. For 20 years, the agency has acted strictly like a private insurance company, going to great lengths to avoid having to pay for any out-of-country care.

“There’s no compassion at all,” said Perry Brodkin, who was the agency’s in-house counsel years ago, before regulatory change changed it from an agency that tries to help to one seeking any reason to reject coverage.

Most patients lose appeals to OHIP rejections because they can’t afford to hire a lawyer, as legal costs typically range between $5,000 and $20,000.

Patients argue on compassionate grounds not to be found in a law that restricts out-of-country coverage to necessary care that’s unavailable here or so delayed a wait would probably result in death or medically significant and irreversible tissue damage.

Pain alone isn’t enough to get OHIP funding, no matter how excruciating or debilitating, Brodkin said.

But this time the bad guys lost, Brodkin said.

Jones won her appeal this month before Ontario’s Health Services Appeal and Review Board.

Board members took issue not just with the stance of OHIP, but also with the Ontario specialists who had essentially told Jones to wait her turn.

The specialist she was to have waited for was Dr. Nicholas Leyland, top dog at Health Sciences Centre at Hamilton’s McMaster University.

But when Jones went to Sinervo, Leyland wrote to support OHIP’s denial of coverage.

“We could have carried out the same kind of care that was provided by Dr. Sinervo, who was a trainee of ours a few years ago. This patient would not have suffered death or irreversible tissue damage in waiting for this surgery. Many patients are waiting for this procedure much longer,” Leyland wrote.

The board rejected Leyland’s claim, noting in his letter, he didn’t mention Jones’ specific condition or if delay would cause irreversible tissue damage, dismissing her claim because some other women with the same general condition had to wait longer.

“It is unfortunate that Dr. Leyland did not testify at the hearing,” the board wrote.

The board also took aim at OHIP: “The Appeal Board is troubled by (OHIP’s) assertion that since endometriosis is by definition a progressive disease, any further progression in the form of tissue damage is expected and is not medically significant.”

The decision is timely, Brodkin said, as waits for surgery by Leyland have grown to nine months, with about 60 women affected.

“Most wait and suffer damage,” he said. “(This case) may open the doors (for care in Atlanta),” Brodkin said.

The Toronto lawyer challenged Ontario Health Minister Deb Matthews to change the rules and process to give patients a fighting chance, even if it’s to arrange for an advocate or ombudsperson for those who can’t afford a lawyer.

As for Sinervo, he’d like to negotiate a reduced rate with the health ministry for Ontario women going to Atlanta’s Center for Endometriosis Care, something close to half of the regular charges.

The Free Press requested interviews three days this week with Matthews, a London MPP, but she didn’t make herself available.

While use of prescription opioids for cancer and other end-of-life pain is increasingly accepted, if you are going to suffer in agony for years, rather than months, mercy is harder to find. Indeed, it seems a given by the media that because addicts sometimes fake pain to get drugs, doctors should treat allpatients as likely liars—and if a physician is conned by an addict, the doctor has only herself to blame.

But do we really want our doctors to treat us as if we were guilty until proven innocent? Do we really want the routine use of invasive procedures—ranging from nerve conduction tests to repeated scans and surgeries—to “prove” we’re really hurting? And do we actually want physicians to be held responsible for the actions of a patient who dissembles and does not take drugs as prescribed?

The answers to these questions are at the heart of the bizarre way we view synthetic opioid medications and the suffering of the 116 million Americans who have moderate to severe chronic pain, according to Institute of Medicine estimates.

In recent weeks, for example, New York Sen. Charles Schumer, anti-drug abuse advocates and reporters have inveighed against the potential FDA approval of an experimental opioid painkiller called Zohydro—professing to be horrified by the introduction of a new class of “100% pure” hydrocodone “superdrugs” that they have already dubbed “the next OxyContins.” And many states are weighing laws like one now in place in Washington state, which limits the doses of opioids that can be used by chronic pain patients.

When people consider the use of these medications in chronic pain, addiction fears are typically the first thing that comes up. Moreover, media coverage rarely includes the perspective of pain patients— or does so only to knock those who advocate for access to opioids as pawns of the pharmaceutical industry.

If the press—often quoting leading public health officials like Dr. Thomas Frieden, the director of the CDC—is to be believed, the US is in the throes of an “epidemic” of prescription painkiller abuse. Frieden even claimed at a recent press conference on opioid-related deaths that doctors are now more responsible than drug dealers for America’s addiction problems. “The burden of dangerous drugs is being created more by a few irresponsible doctors than drug pushers on street corners,” Friedman said.

However, the opioid issue looks very different when you examine the numbers closely. For one, the rates of Americans addicted to OxyContin, Vicodin, percocet, fentanyl and other products in our synthetic narcotic medicine cabinet are not rising. In fact, they have been steady at 0.8% since 2002, according to the government’s own statistics.

Moreover, fewer than 1% of people over 30 (without a prior history of serious drug problems) become an addict while taking opioids; for chronic pain patients who are not screened for a history of previous drug problems, the addiction rate is 3.27%. That means, of course, that more than 96% do not become addicted.

Yet these statistics usually go unmentioned in media accounts because they do not confirm the preferred panic narrative. Also left out is the fact that around 80% of Oxy addicts (a) did not obtain the drug via legitimate prescription for pain and/or (b) had a prior experience of rehab. Their contact with the medical system—if any—was not what caused their addictions.

So, the first thing the public really needs to know about what doctors call “iatrogenic addiction” is that it is extremely rare. If you’ve made it out of your 20s without becoming an addict, the chances that you will get hooked on pain treatment are miniscule—and even young people are not at high risk in most medical settings.

Nonetheless, the media continue to love them some “innocent victims”—and the real story of not-so-blameless drug users who move from heavy drinking, cocaine use and marijuana smoking to prescription drug abuse is just not as compelling. This, sadly, only contributes to the delusion that anyone who is treated for chronic pain with opioids is at risk for drowning in the—gasp!—ubiquitous riptide of addiction.

The panic leads to policies that require pain patients to be urine-tested, to be called in to their doctors’ offices for random “pill counts” and to make frequent visits—all of which is not only humiliating but expensive and time-consuming. There’s little evidence that such policing prevents addiction or does anything else beyond inconveniencing and stigmatizing pain patients.

And indeed, the stigma of addiction is what’s behind the curtain here. Imagine suffering from incurable daily pain so severe that it feels like your legs are being dipped in molten iron or your spine is being scraped out by sharp talons. Even if you did, in a worst-case scenario, join the tiny percentage of patients who develop a new addiction and became obsessed with using opioids, would this really be worse, especially if you had safe and legal access to them?

Most of the physical and psychological horrors of addiction come with loss of control and with being unable to be present for family, work and friends. But pain can produce even greater dysfunction and emotional distance, and its ability to destroy relationships is at least as monstrous. Moreover, maintenance on opioids can typically stabilize people with addictions, without numbing or incapacitating them. So why do we panic?

In the absence of true pharmaceutical innovation (Zohydro and other “superdrugs” are mere purer versions of VIcodin without the acetaminophen ), opioids remain the only medications that can even begin to touch severe pain, though they are far from perfect. But since they rarely lead to addiction—and since addiction (or opioid maintenance treatment) may actually sometimes be the lesser of evils—does it really make sense to restrict and even deny their benefits to pain patients?

When the situation is considered rationally, our outsized fear of addiction has little to do with the reality of chronic pain. Instead, it’s about the way we see addicts: gun-toting robbers of Oxy from pharmacies and other scummy, lying, sociopathic criminals—people we don’t want to be around or become.

Even though readers of this site know that drugs don’t somehow “make” ordinary people into such demonic figures—and that addicts can also be as kind, compassionate and hard-working as anyone else— the stigma runs deep.

Much of it, I think, comes from the same evasion of responsibility that allows us to blame doctors for addictions. After all, it’s not doctors who tell their patients to inject or snort their oral painkillers, to drink while taking opioids, to take more than prescribed or to lie, cheat and steal to obtain them.

These actions are deliberately taken by drug seekers. Doctors don’t “make” anyone make the ongoing choices that lead to impaired self-control. While trauma histories, psychiatric disorders like depression and/or genetics do make some of us more vulnerable to taking this path, no one can force us to do it. And if we see doctors—or, for that matter, dealers—as having “caused” our addictions, we open ourselves up to be dehumanized and stigmatized.

That is because if we are seen as incapable of making good choices, how can we expect respect for our desires and preferences? If we can’t control ourselves, why shouldn’t we be incarcerated to protect others from our actions? After all, when the public sees us as mindless zombies, their response is not sympathy for our supposed powerlessness but fear and disgust at our imagined violence.

Even the overdose issue is mismanaged due to our hatred of addicts. Overdoses have now overtaken car accidents as a leading cause of accidental death, but it’s unclear how much of this increase is due to the actual rise in the use of opioids and how much to medical examiners simply attributing more deaths to these drugs since they are now found in more dead people. What is clear is that most of these deaths occur in the context of drug abuse—95%, according to one study of one of the hardest-hit states. A large number of these deaths could be prevented by providing the antidote to opioid poisoning, naloxone, with prescriptions for the drugs. But because we want the wages of sin to be death, however, drug warriors have largely prevented funding for programs to broadly distribute that lifesaving medication.

The opioid problem is really the stigma of addiction writ large. Consequently, if we want to stop getting in the way of access to painkillers for people who genuinely need them, we need to take responsibility for our own actions and help fight this stigma. No one but you can make yourself into an addict. But chronic pain can happen to anyone.

Reporting from Washington — The Food and Drug Administration will limit the amount of the pain reliever acetaminophen allowed in commonly used prescription drugs such as Percocet and Vicodin to reduce the danger of harm to the liver.

But Thursday’s announcement, setting a maximum of 325 milligrams per prescription pill, will not affect over-the-counter products containing acetaminophen, which is best known by the brand name Tylenol.

Acetaminophen is usually paired with painkilling opioids like hydrocodone or oxycodone and such combination products are prescribed nearly 200 million times per year, making them among the most widely used prescription drugs.

Acetaminophen is valued as a pain reliever in part because, unlike other common analgesics such as aspirin, ibuprofen and naproxen, it does not cause gastric bleeding or other stomach discomfort.

But regulators have long worried about liver damage from the drug, particularly when taken in excess of a 4,000-milligram daily limit or with alcohol.

Acetaminophen overdose is the leading cause of liver failure and the leading cause of death from liver failure in the U.S. Overdoses accounted for 56,000 hospital emergency room visits and were linked to an average of 458 deaths annually during the 1990s, according to FDA data.

Avoiding overdose can be challenging because the drug is blended into so many cold preparations and pain relievers.

The FDA is not taking any action affecting the levels of opioids in the drugs, and the lowering of the acetaminophen dosage won’t affect their pain-relieving quality, said Sandra Kweder, a senior official in the FDA’s drug office, who briefed reporters on the changes.

“We don’t believe we are making these products less effective,” said Kweder, who noted that the combination drugs were introduced with lower doses of acetaminophen that crept upward over time.

The elimination of versions of drugs containing up to 750 milligrams of acetaminophen will be phased in over three years and is not expected to create shortages of pain medication.

While the FDA’s action will lessen the strain of acetaminophen-opioid combinations on the liver, it may have the unintended consequence of increasing abuse of the drugs, said Frank Palumbo, director of the University of Maryland’s Center for Drugs and Public Policy.

“I think it’s a double-edged sword,” Palumbo said. “Some patients may be tempted to take more of the opioid.”

The FDA’s restrictions are less stringent than the suggestions of an agency advisory committee, which by a narrow margin in July 2009 recommended a ban on Percocet and Vicodin.

Kweder said limiting the amount of acetaminophen was “a more reasoned and reasonable” approach that would not disrupt pain management programs.

In a statement, Abbott Laboratories, the maker of Vicodin, said it was “evaluating the FDA’s guidance and will determine how best to comply.”

One prescription drug containing acetaminophen, known by the Darvocet brand name, was removed from the market at the FDA’s request in November because of concerns about the heart toxicity of propoxyphene, the other active ingredient in the product.

Elimination of acetaminophen in higher dosages in prescription compounds means that it will be available on its own in a higher strength — 500 milligrams — in both over-the-counter and prescription versions.

The 2009 advisory committee recommended imposing a maximum strength of 325 milligrams for over-the-counter acetaminophen, but Kweder said the FDA hadn’t decided what actions, if any, it would take.

Sidney Wolfe, director of the nonprofit Public Citizen’s Health Research Group and a member of the advisory committee, lauded the FDA for its action on prescriptions, but he said the agency also should have restricted the size of over-the-counter doses because they make up 80% of the acetaminophen market.

To anyone who uses Vicodin, Percoset, Darvocet, Lortab, and any meds that contain Acetaminophen, read this!
This has been in the news before, when a group originally petitioned the FDA, but the FDA has now voted. The ban could be real and official very soon.

Excerpt:“If the combination products are eliminated, the acetaminophen and the other ingredients could be prescribed separately. In effect, patients would take two pills instead of one, and be more aware of the acetaminophen they are consuming.”

I currently take Tylenol 3 and Motrin for endometriosis pain each month. Last year, my liver enzymes were high, and I had to go off of Tylenol for three months until my liver stabilised again. I’ve tried codeine directly without any Tylenol in it, because my GYN is so against the use of Tylenol. But I have bad side effects to codeine. Mixing it with Tylenol seems to work better for me. See my growing list of medications I’ve tried to fight the pain.

So this whole advisory vote is a bit unnerving for me. I need to find alternate working choices for medication, and fast.

ADELPHI, Md. — Government experts called for sweeping safety restrictions Tuesday on the most widely used painkiller, including reducing the maximum dose of Tylenol and eliminating prescription drugs such as Vicodin and Percocet.

The Food and Drug Administration assembled 37 experts to recommend ways to reduce deadly overdoses with acetaminophen, which is the leading cause of liver failure in the U.S. and sends 56,000 people to the emergency room annually. About 200 die each year.

“We’re here because there are inadvertent overdoses with this drug that are fatal and this is the one opportunity we have to do something that will have a big impact,” said Dr. Judith Kramer of Duke University Medical Center.

But over-the-counter cold medicines – such as Nyquil and Theraflu – that combine other drugs with acetaminophen can stay on the market, the panel said, rejecting a proposal to take them off store shelves.

The FDA is not required to follow the advice of its panels, though it usually does. The agency gave no indication when it would act on the recommendations.

In a series of votes Tuesday, the panel recommended 21-16 to lower the current maximum daily dose of over-the-counter acetaminophen from 4 grams, or eight pills of a medication such as Extra Strength Tylenol. They did not specify how much it should be lowered.

The panel also endorsed limiting the maximum single dose of the drug to 650 milligrams. That would be down from the 1,000-milligram dose, or two tablets of Extra Strength Tylenol.

A majority of panelists also said the 1,000-milligram dose should only be available by prescription.

The industry group that represents Johnson & Johnson, Wyeth and other companies defended the current dosing that appears on over-the-counter products.

“I think it’s a very useful dose and one that is needed for treating chronic pain, such as people with chronic osteoarthritis,” said Linda Suydam, president of the Consumer Healthcare Products Association.

The experts narrowly ruled that prescription drugs that combine acetaminophen with other painkilling ingredients should be eliminated. They cited FDA data indicating that 60 percent of acetaminophen-related deaths are related to prescription products.

But some on the panel opposed a sweeping withdraw of products that are widely used to control severe, chronic pain. Prescription acetaminophen combination drugs were prescribed 200 million times last year, according to the FDA.

“To make this shift without very clear understanding of the implications on the management of pain would be a huge mistake,” said Dr. Robert Kerns of Yale University.

If the drugs stay on the market, they should carry a black box warning, the most serious safety label available, the panel decided.

“If we don’t eliminate the combination products we should at least lower the levels of acetaminophen contained in those medicines,” said Sandra Kewder, FDA’s deputy director for new drugs, summarizing the panel’s vote.

Percocet and similar treatments combine acetaminophen with more powerful pain relieving narcotics, such as oxycodone.

If the combination products are eliminated, the acetaminophen and the other ingredients could be prescribed separately. In effect, patients would take two pills instead of one, and be more aware of the acetaminophen they are consuming.

Vicodin is marketed by Abbott Laboratories, while Percocet is marketed by Endo Pharmaceuticals. Both painkillers also are available in cheaper generic versions.

Drug companies avoided the most damaging potential outcome with the defeat of proposal to pull NyQuil and other over-the-counter cold and cough medicines that combine acetaminophen with other drugs.

These drugs can be dangerous when taken with Tylenol or other drugs containing acetaminophen, according to the FDA, but cause only 10 percent of acetaminophen-related deaths.

“I don’t think we should be advocating a solution to a problem that really is not there,” said Dr. Osemwota Omoigui, of the Los Angeles pain clinic.

A recall of combination cold medicines would have cost manufacturers hundreds of millions of dollars in revenue. Total sales of all acetaminophen drugs reached $2.6 billion last year, with 80 percent of the market comprised of over-the-counter products, according to IMS Health, a health care analysis firm.

“The acetaminophen people dodged a bullet,” said Erik Gordon, a University of Michigan business professor who studies the biomedical industry.

Even with the lower daily dosage recommendation, consumers will likely keep taking as many pills as they think they need to ease their pain, Gordon said.

Analyst Steve Brozak of WBB Securities said the panel votes were a “shot across the bow” of the pharmaceutical industry.

“This basically puts more government oversight into something that heretofore has been less than present,” Brozak said.

WASHINGTON — Many doctors may lose their ability to prescribe 24 popular narcotics as part of a new effort to reduce the deaths and injuries that result from these medicines’ inappropriate use, federal drug officials announced Monday.

A new control program will result in further restrictions on the prescribing, dispensing and distribution of extended-release opioids like OxyContin, fentanyl patches, methadone tablets and some morphine tablets.

These products are classified as Schedule II narcotics and already are restricted according to rules jointly administered by the Food and Drug Administration and the Drug Enforcement Agency. But the current restrictions have failed to “fully meet the goals we want to achieve,” said Dr. John K. Jenkins, director of the F.D.A.’s new drug center.

“What we’re talking about is putting in place a program to try to ensure that physicians prescribing these products are properly trained in their safe use, and that only those physicians are prescribing those products,” Dr. Jenkins said in a news conference on Monday. “This is going to be a massive program.”

Hundreds of patients die and thousands are injured every year in the United States because they were inappropriately prescribed drugs like OxyContin or Duragesic or they took the medicines when they should not have or in ways that made the drugs dangerous. The agency has issued increasingly urgent warnings about the risks, but the toll has only worsened in recent years.

The blame for this is shared among doctors who prescribe poorly, patients who pay little attention to instructions or get access to the medicines inappropriately, and companies that have marketed their products illegally.

The F.D.A. this year will hold meetings with manufacturers, patient and consumer advocates, and the public to ask for advice on how to carry out the new control program, officials announced. The first meeting will be on March 3, and no immediate changes in access to the drugs is planned.
(A complete list of the drugs is at www.fda.gov/cder.)

But many doctors prescribe the drugs far too cavalierly, Dr. Jenkins said. The F.D.A. has received reports of patients’ being prescribed such medicines to treat something as simple as a sprained ankle, he said. In such patients, the medicines can be dangerous.

Part of the problem is marketing. Several reports, for instance, have suggested that Purdue Pharma, the maker of OxyContin, helped fuel widespread abuse of the drug by aggressively promoting it to general practitioners not skilled in either pain treatment or in recognizing drug abuse.

The company has denied such a connection, but a holding company connected with Purdue and three top Purdue executives pleaded guilty last year to criminal charges that the company had misled doctors and patients by claiming for five years that OxyContin was less prone to abuse because it was a long-acting narcotic.

Doctors are also to blame. A common reason for disciplinary actions at state medical boards is the use of narcotics in patients who show clear signs of addiction or for whom the drugs are obviously inappropriate.

The F.D.A. generally avoids interfering with the practice of medicine because doctor behavior is governed by state medical boards. Instead, the agency usually tries to provide doctors with the best and most current information, and then allows them to decide how to use it.

Most of the drugs withdrawn over the last 20 years, however, were taken off the market because doctors continued to use the medicines in ways that the F.D.A. warned against.

For decades, the agency’s armory in these battles held only a popgun and a cannon — the popgun being the issuance of widely ignored warnings; the cannon being its ability to force a medicine’s withdrawal. But a law passed in 2007 gave the agency a new, intermediate weapon — Risk Evaluation and Mitigation Strategies. Known as REMS, these programs allow the agency to place strong restrictions on the distribution of certain drugs.

EAST ST. LOUIS — The U.S. government is asking a federal judge to trim an $8.6 million judgment over an Air Force base doctor’s mistreatment of a case of flesh-eating bacteria that cost a woman use of an arm.

Federal prosecutors this week asked federal Magistrate Judge Philip Frazier to reconsider his ruling favoring Jean Phillips, an Air Force captain’s former wife, who the judge concluded was left with a right arm that’s been “withered, lifeless and useless” since 2002.

Frazier, after an August bench trial, found that Dr. Dan MacAlpine was stationed at Scott Air Force Base just east of St. Louis when he failed to notice or heed Phillips’ rash on her right arm in 2002, assuming she was an addict looking for prescription drugs. MacAlpine told her to go home and take Motrin, a popular over-the-counter pain medication.

But the rash turned out to be necrotizing fasciitis, commonly known as flesh-eating bacteria, that Frazier says eventually cost Phillips use of her right arm.

“This is a sad story,” Frazier wrote in his 13-page ruling Nov. 25. With a useless arm that causes her continuous, extreme pain and likely hooked on prescription drugs, the judge added, the now-divorced Phillips “faces the future with no reason to be optimistic that things will improve.”

Frazier awarded $2.5 million each for future pain and suffering and for future disability, as well as $1.5 million for past pain and suffering. The judge also said Phillips should get $500,000 apiece for past disability and disfigurement, $495,169 for past and future lost earnings, $421,581 for past medical costs and $215,040 for future ones.

Frazier credited the government for $110,748 in medical services already rendered.

“Granted, there are more dramatic injuries out there involving multiple amputations and the like,” Frazier wrote. “But (Phillips’) situation is about as bad as it gets when one considers the impact on her work and personal life.”

The judge acknowledged Phillips’ life already “was on a downward arc” when she contracted the flesh-eating bacteria, noting she had poor health including issues with abnormal uterine tissue growth called endometriosis, hypothyroidism, insomnia, headaches and anxiety. Frazier said she also had emotional troubles and perhaps drug addiction.

But “she had one other thing that she does not have today. She had a chance,” the judge wrote. “The cruel reality is that her life would probably improve if the arm were taken” — amputated to make way for a prosthetic arm she actually could use.

In its motion Wednesday, the U.S. government, which operates Scott Air Force Base through the Defense Department, asked Frazier to lower the damages he assessed for Phillips’ past and future medical expenses and her lost wages. Those damages total $1,131,790.

According to the government, Phillips’ future medical expenses beyond 10 years from now required speculation, perhaps making her eligible for $48,000 — not $215,040 as Frazier ruled. And “there is simply no evidence in the record that (Phillips) was willing or able to work even prior to her necrotizing fasciitis,” Wednesday’s motion read in questioning the woman’s eligibility for lost earnings.

Phillips’ attorney, Thomas Keefe Jr., was out of the office Friday and unavailable until next week, according to his office, which declined to disclose where Phillips now lives. A published telephone listing could not be found.

MacAlpine now lives in Iowa, where a woman who answered his home telephone Friday said the 39-year-old doctor had no comment. The AP left a message.

Randy Massey, a spokesman for Southern Illinois’ U.S. attorney’s office representing the federal government in the case, declined comment Friday.